Swedish Match USA, Inc., MRTP Applications
On November 7, 2024, the FDA issued modified risk granted orders to Swedish Match USA, Inc. (previously known as Swedish Match North America, Inc.), for the following snus smokeless tobacco products to continue to be marketed as MRTPs with the authorized claim, "Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."
- General Loose
- General Dry Mint Portion Original Mini
- General Portion Original Large
- General Classic Blend Portion White Large-12ct
- General Mint Portion White Large
- General Nordic Mint Portion White Large-12ct
- General Portion White Large
- General Wintergreen Portion White Large
This is the first renewal of modified risk granted orders issued by FDA. These modified risk granted orders issued by FDA are specific to the above-mentioned products and expire November 7, 2032. These products were originally authorized for marketing in the U.S. via the premarket tobacco product application pathway in 2015. In October 2019, the products were then authorized to be marketed as modified risk tobacco products. Those 2019 orders permitting marketing of General Snus products as modified risk tobacco products were valid for 5 years.
Updates to Application
- On November 30, 2023, FDA filed for scientific review renewal modified risk tobacco product (MRTP) application submitted by Swedish Match USA, Inc. for the General Snus products. The original modified risk granted orders were valid for a term of five years from the date of issuance. To continue marketing an MRTP with the modified risk claim after the term of an order, FDA must issue a renewal authorization after making the determination that the requirements in section 911 of the Federal Food, Drug, and Cosmetic Act continue to be met. Renewal applications may cross-reference an applicant’s original MRTP application as well as postmarket annual reports submitted in accordance with the order requirements for both the premarket tobacco application (PMTA) and MRTP authorizations. Annual reports for MRTPs contain the results from the postmarket surveillance and studies that all companies are required to conduct as part of a modified risk granted order.
- On June 26, 2024, FDA held a TPSAC meeting to discuss these renewal applications.
- On July 3, 2024, FDA reposted the following files:
- On July 15, 2024, FDA reposted Annual Reports Part 8.
- On November 7, 2024, FDA renewed the modified risk granted orders to Swedish Match USA Inc., for the General Snus products.
Public comments on these applications were submitted to docket FDA-2014-N-1051-0941 on regulations.gov. See the Modified Risk Orders webpage for order letters and decision summaries relevant to these actions.
Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted. The latest set of application materials from Swedish Match USA, Inc. were made available on July 15, 2024.
Materials and Related Documents
Temporary Compliance Waiver: The linked files may not be fully accessible to readers using assistive technology. We regret any inconvenience that this may cause. In the event you are unable to read these documents or portions thereof, please email AskCTP@fda.hhs.gov or call 1-877-287-1373.
Additional materials related to the actions include:
Swedish Match USA, Inc. MRTP Application Renewal – updated November 7, 2024
- FDA Decision Summary (PDF - 3056 KB) - posted November 7, 2024
- FDA Order Letter (PDF - 742 KB) - posted November 7, 2024
- Swedish Match USA, Inc. MRTP Renewal Applications (zip* – 7.3 MB) – posted November 30, 2023
- Updated Swedish Match USA, Inc. MRTP Renewal Applications (3.6 MB) – posted July 3, 2024
- FDA will post application documents, including amendments, on a rolling basis as the documents are redacted.
- Cross-referenced submissions to support the application are listed below.
- Original PMTA and Amendments (Authorized November 10, 2015) – posted November 30, 2023 (zip – 62 MB)
- December 13, 2023, Amendment: Response to FDA Request for Clarification – posted June 5, 2024 (zip – 3 MB); updated July 3, 2024
- Updated December 13, 2023, Amendment: Response to FDA Request for Clarification (4.7 MB) – posted July 3, 2024
- January 17, 2024, Amendment: Updated information to the original renewal – posted June 5, 2024 (zip – 8 MB)
- January 30, 2024, Amendment: Response to January 17, 2024, Deficiency letter – posted June 5, 2024 (zip – 6 MB)
- February 13, 2024, Amendment: Response to January 17, 2024, Deficiency letter – posted June 5, 2024 (zip – 2 MB)
- 2016 Annual Reports Part 1 (zip – 31.87 MB)
- 2016 Annual Reports Part 2 (zip – 57.02 MB)
- 2016 Annual Reports Part 3 (zip – 57.66 MB)
- 2016 Annual Reports Part 4 (zip – 56.92 MB)
- 2016 Annual Reports Part 5 (zip – 57.21 MB)
- 2016 Annual Reports Part 6 (zip – 55.10 MB)
- 2016 Annual Reports Part 7 (zip – 57.10 MB)
- 2016 Annual Reports Part 8 (zip – 4.77 MB)
- 2016 Annual Reports Part 9 (zip – 5.04 MB)
- 2017 Annual Reports Part 1 (zip – 12.93 MB)
- 2017 Annual Reports Part 2 (zip – 12.62 MB)
- 2017 Annual Reports Part 3 (zip – 13.08 MB)
- 2017 Annual Reports Part 4 (zip – 2.85 MB)
- 2017 Annual Reports Part 5 (zip – 12.83 MB)
- 2017 Annual Reports Part 6 (zip – 2.65 MB)
- 2017 Annual Reports Part 7 (zip – 43.64 MB)
- 2017 Annual Reports Part 8 (zip – 11.26 MB)
- 2017 Annual Reports Part 9 (zip – .001 MB)
- 2020 Annual Reports Part 1 (zip – 10.13 MB)
- 2020 Annual Reports Part 2 (zip – 29.13 MB)
- 2020 Annual Reports Part 3 (zip – 1.89 MB)
- 2020 Annual Reports Part 4 (zip – 1.85 MB)
- 2020 Annual Reports Part 5 (zip – 9.70 MB)
- 2020 Annual Reports Part 6 (zip – 10.12 MB)
- 2020 Annual Reports Part 7 (zip – 28.55 MB)
- 2020 Annual Reports Part 8 (zip – 28.55 MB)
- 2020 Annual Reports Part 9 (zip – 9.70 MB)
- 2020 Annual Reports Part 10 (zip – 2.00 MB)
- 2020 Annual Reports Part 11 (zip – .75 MB)
- 2020 Annual Reports Part 12 (zip – .62 MB)
- 2021 Annual Reports Part 1 (zip – 1.49 MB)
- 2021 Annual Reports Part 2 (zip – 90.18 MB)
- 2021 Annual Reports Part 3 (zip – 18.01 MB)
- 2021 Annual Reports Part 4 (zip – 18.01 MB)
- 2021 Annual Reports Part 5 (zip – 38.76 MB)
- 2021 Annual Reports Part 6 (zip – 66.54 MB)
- 2021 Annual Reports Part 7 (zip – 43.84 MB)
- 2021 Annual Reports Part 8 (zip – 84.19 MB)
- Updated 2021 Annual Reports Part 8 (zip – 235 MB) posted July 15, 2024
- 2021 Annual Reports Part 9 (zip – 1.50 MB)
- 2021 Annual Reports Part 10 (zip – 1.50 MB)
- 2021 Annual Reports Part 11 (zip – 23.11 MB)
- 2021 Annual Reports Part 12 (zip – 17.19 MB)
- 2021 Annual Reports Part 13 (zip – 1.49 MB)
- 2022 Annual Reports Part 1 posted November 30, 2023 (zip – 4.36 MB)
- 2022 Annual Reports Part 2 posted November 30, 2023 (zip – 15.37 MB)
- 2022 Annual Reports Part 3 posted November 30, 2023 (zip – 12.22 MB)
- 2022 Annual Reports Part 4 posted November 30, 2023 (zip – .03 MB)
- 2022 Annual Reports Part 5 posted November 30, 2023 (zip – 6.11 MB)
- 2022 Annual Reports Part 6 posted November 30, 2023 (zip – 59.34 MB)
- 2022 Annual Reports Part 7 posted November 30, 2023 (zip – 575.38 MB)
- 2022 Annual Reports Part 8 posted November 30, 2023 (zip – .06 MB)
- 2022 Annual Reports Part 9 posted November 30, 2023 (zip – .06 MB)
- 2022 Annual Reports Part 10 posted June 5, 2024 (zip – 66 MB)
- 2022 Annual Reports Part 11 posted June 5, 2024 (zip – 856 KB)
- 2022 Annual Reports Part 12 posted June 5, 2024 (zip – 722 MB)
- 2022 Annual Reports Part 13 posted June 5, 2024 (zip – 340 MB)
- 2022 Annual Reports Part 14 posted June 5, 2024 (zip – 24 MB)
- 2023 Annual Reports Part 1 (zip – 11 MB)
- 2023 Annual Reports Part 2 (zip – 11 MB)
- 2023 Annual Reports Part 3 (zip – 54 MB)
- 2023 Annual Reports Part 4 (zip – 181 MB)
- 2023 Annual Reports Part 5 (zip – 69 MB)
- 2023 Annual Reports Part 6 (zip – 433 MB)
Swedish Match USA, Inc. MRTP Application – Authorized on Oct. 22, 2019
- FDA Decision Summary (PDF – 5 MB) – posted December 14, 2016
- FDA Response Letter (PDF – 65 KB) – posted December 14, 2016
- FDA Denial Letters (.zip – 282 KB) – posted December 14, 2016
- Summary of Applications (PDF – 32 MB) (posted August 27, 2014; updated January 16, 2019
- FDA initially redacted certain harmful and potentially harmful constituents (HPHC) information on pp. 517-544 (internal document pagination), which were later made publicly available. The current version reflects the removal of these redactions.
- Swedish Match North America, Inc. MRTP Applications (zip*, 813 files, 1.7 GB) – posted August 27, 2014
- We have numbered the files to help you navigate through the materials in a logical order. For example, start with "01 application narrative summary_Redacted.pdf," proceed to "02 appendix-2a-iom-2012_Redacted.pdf," etc.
- Amendments to the Applications
- Amendments to Swedish Match North America, Inc. MRTP Applications Received After Filing, (.zip – 1.14 GB) posted July 31, 2015
- September 17, 2018 Amendment: Response to FDA's December 14, 2016 Letter (.zip 65 MB) posted October 10, 2018
- November 28, 2018 Amendment: Response to October 24, 2018, FDA Advice and Information Request Letter (.zip – 114 MB) posted December 17, 2018
- January 30, 2019 Amendment: Amended Response to October 24, 2018, FDA Advice and Information Request Letter (.zip – 5 MB) posted February 1, 2019
* These ZIP files include several individual files. Depending on your Internet connection speed and other factors, it may take a few minutes or up to several hours to download a ZIP file completely.
Note: We are required by section 911(e) of the Federal Food Drug & Cosmetic Act, as amended by the Tobacco Control Act, to make modified risk tobacco product (MRTP) applications available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments on the information contained in the applications and on the label, labeling, and advertising accompanying the applications. Please visit our Modified Risk Tobacco Products web page for more information.
Additional Resources
- FDA Authorizes Modified Risk Tobacco Products
- October 22, 2019 – FDA grants first-ever modified risk orders to eight smokeless tobacco products
- Tobacco Products Scientific Advisory Committee: February 2019 Meeting Materials
- December 14, 2016 - FDA takes action on applications seeking to market modified risk tobacco products
- Perspective: Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) Applications
- November 10, 2015 - FDA issues first product marketing orders through premarket tobacco application pathway
- Tobacco Product Scientific Advisory Committee (TPSAC) – April 2015 Meeting Materials
- TPSAC Meetings on MRTP Applications
- MRTP Overview